Zydus, Alembic Pharma recall drugs in US over life-threatening consequences
New Delhi: US-based arms of domestic pharma firms Zydus Cadila and Alembic Pharmaceuticals are recalling one drug each in the US after receiving complaints against the products.
Zydus Pharmaceuticals (USA) Inc and Alembic Pharmaceuticals Inc are voluntarily recalling the products, the companies said in separate announcements posted by the US health regulator on its website.
Zydus Pharmaceuticals (USA) Inc is voluntarily recalling four lots of Acyclovir Sodium Injection, 50 mg/mL, 10 mL and 20 mL vials, to the hospital/user level after receiving several complaints of crystallization in vials, the company said.
Administration of crystallized Acyclovir Sodium Injection, 50 mg/mL has a potential of life-threatening adverse consequences, it added.
"To date, Zydus Pharmaceuticals (USA) Inc has not received any reports of adverse events related to this product recall," the company said.
The company has notified its distributors and customers by email and FedEx overnight courier service and is arranging for the return of all recalled Acyclovir Sodium Injection, 50 mg/mL lots.
Hospitals that have the product which is being recalled should stop using it immediately and call the company''s recall coordinating center, it added.
Another firm Alembic Pharmaceuticals Inc is voluntarily recalling one lot of Telmisartan tablets, USP, 20 mg, packaged in 30-count bottles to the consumer level, the company said in an announcement on the United States Food and Drug Administration''s (USFDA) website.
The product is being recalled due to a market complaint received which stated that one bottle labelled as 30-count Telmisartan tablets, USP, 20 mg incorrectly contained 30 tablets of Telmisartan, USP, 40mg, it added.
Patients who could be on a double dose of Telmisartan for a prolonged period of time, could experience low blood pressure, worsening of kidney function, or an elevation of potassium which can be life-threatening, the company said.
"To date, Alembic Pharmaceuticals Ltd has not received any reports of adverse events related to this recall," it added.
Alembic Pharmaceuticals Ltd is notifying its distributors and retailers through a letter and is arranging for the return of the recalled lot, the company said.